Status:
COMPLETED
Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR
Lead Sponsor:
Centre Hospitalier of Chartres
Collaborating Sponsors:
Hospital of Chartres- France
Conditions:
Skin Diseases
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether cetuximab is effective in the treatment of locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.
Detailed Description
Patients with locally advanced or metastatic squamous cell carcinoma (SCC) of the skin are often bad responders to conventional chemotherapy included cisplatin. The investigation of the EGFR expressi...
Eligibility Criteria
Inclusion
- Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and +++, on a semi-quantitative scale).
- Locally advanced or metastatic SCC of the skin not suitable for local surgery with documented progression.
- Presence of at least one measurable target lesion by RECIST criteria.
- At least one lesion accessible to biopsies.
- ECOG Performance status \< 2.
- Life expectancy \> 3 months.
- Age \> 18 years.
- Normal hematological (Neutrophils \> 1.5x109 cells/l, platelets \> 100x109 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range (ULN); alkaline phosphatase and transaminases \< 5 x UNL in case of hepatic metastases or \< 2.5 x UNL in absence of hepatic metastases) and renal (serum creatinine \< 150 micromol/L) functions.
- Written informed consent.
- In case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.
Exclusion
- Prior chemotherapy
- Prior radiotherapy \< 1 month.
- Prior therapy with agent targeting EGFR
- Unstable systemic diseases or active uncontrolled infections.
- Patients (male and female) not using effective contraception if of reproductive potential.
- Females pregnant or lactating. Women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00240682
Start Date
October 1 2005
End Date
June 1 2009
Last Update
February 22 2012
Active Locations (14)
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1
Hospital of Caen
Caen, France, 14000
2
Hospital of Chartres
Chartres, France, 28018
3
Hospital Hôtel Dieu
Clermont-Ferrand, France, 63058
4
Beaujon's Hospital
Clichy, France, 92110